Device Recall BENEPHIT CV Infusion System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics Worldwide Headquarters 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61123
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1113-2012
  • 사례 시작날짜
    2012-02-06
  • 사례 출판 날짜
    2012-02-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, continuous flush - Product Code KRA
  • 원인
    The benephit cv infusion system contains a sheath y connector that has the potential to develop cracks.
  • 조치
    Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to customerservice@angiodynamics.com

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 550790
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas.
  • 제품 설명
    AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. || Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • 제조사 모회사 (2017)
  • Source
    USFDA